Using advanced MRI and biomarkers to improve prostate cancer detection
Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
This study is testing if using a special scoring system with advanced MRI and certain blood and urine tests can help find prostate cancer better in men who need a biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04240327 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate whether the combination of a habitat risk score algorithm applied to multiparametric MRI (mpMRI) and a panel of blood and urine biomarkers can enhance the detection of prostate cancer compared to the standard mpMRI interpretation using the Prostate Imaging Reporting and Data System (PIRADS). The study will involve male participants aged 40-85 who are referred for prostate biopsy due to elevated PSA levels or abnormal digital rectal exams. Participants will be monitored for their health status and must agree to avoid testosterone supplementation during the study period.
Who should consider this trial
Good fit: Ideal candidates are males aged 40-85 with elevated PSA levels or abnormal DRE results who are referred for prostate biopsy.
Not a fit: Patients with a history of prostate cancer or those who have undergone recent prostate procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate prostate cancer diagnoses and better management strategies for patients.
How similar studies have performed: While the use of mpMRI and biomarkers in prostate cancer detection is being explored, this specific combination of methods is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male participant, aged 40-85 years. 2. In good general health as evidenced by medical history. 3. Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE). 4. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers. Exclusion Criteria: 1. Previous or current history of prostate cancer or treatment for prostate cancer. 2. Previous history of pelvic radiation. 3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity. 4. Inability to undergo blood draw or biopsy of the prostate as per protocol. 5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation. 6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial. 7. Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs. 8. Patients with impaired decision-making capacity.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sanoj Punnen, MD, MAS — University of Miami
- Study coordinator: Elena M Cortizas, MS
- Email: ecortizas@med.miami.edu
- Phone: 305-243-6438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.